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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of low-power laser in amelioration of pain , dysesthesia and Lhermitte’s sign in multiple sclerosis patients
Scientific title
The efficacy of low-power laser in addition to Gabapentin, compared to treatment with Gabapentin alone in the amelioration of pain and improvement of quality of life in multiple sclerosis patients
Secondary ID [1] 262136 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 265814 0
pain 267994 0
Quality of life 267996 0
dysesthesia 268303 0
Lhermitte's sign 268304 0
Condition category
Condition code
Neurological 265966 265966 0 0
Multiple sclerosis
Anaesthesiology 268126 268126 0 0
Pain management

Study type
Description of intervention(s) / exposure
different Probe that will be used on cervical and thoracic spinal culomn one after another:
1) MLO1K: Helium, Neon, Argon Amplitude: 500-670 nm Duration: 1-5 min Power: 20 j/cm2
2) KLO6: Helium, Neon Amplitude: 500-670 nm Duration: 10-40 second Power: 172 j/cm2
3) KLO3: Helium, Neon Amplitude: 500-670 nm Duration: 10-30 second Power: 10/5 j/cm2
4) RED Amplitude: 500-660 nm Power: 10/9 j/cm2

Duration of laser therapy in each session: 10-15 min
Location: cervical and thoracic spinal cord
Frequency of sessions: once daily for 10 days(5 continuous days, 2 days rest, and another 5 continuous days)

Laser and Gabapentin capsule (300mg/day) will be administered simultaneously.
Intervention code [1] 264582 0
Treatment: Drugs
Intervention code [2] 266682 0
Treatment: Devices
Comparator / control treatment
Sham therapy for 10 session plus Gabapentin capsule(300mg/day) once daily for 10 days(5 continuous days, 2 days rest, and another 5 continuous days).
For the patients who should receive sham therapy, operator use the turned off laser probe
Control group

Primary outcome [1] 266757 0
Visual analogue scale score for pain.
Timepoint [1] 266757 0
Just after the last session and 2 weeks after that.
Secondary outcome [1] 276317 0
SF-36 questionnaire for quality of life.
Timepoint [1] 276317 0
Just after last session and 2 weeks after that.

Key inclusion criteria
Definitive diagnosed MS with MC-donald 2010 criteria
Cervical pain, Lhermitte's sign, painful dysesthesia in upper limbs or pain in lumbar and pelvic regions and dysesthesia in shoulder girdle.
Minimum age
18 Years
Maximum age
55 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
MS attack or need for corticosteroid pulses.
Addiction or using drugs simultaneous with therapy.
Simultaneous using of regular powerful anti-inflammatory drugs
Other causes except than spinal cord plaques produce pain, dysesthesia and Lhermitte's sign.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be done by person who is not involved in enrolling the patients and writes intervention group(A or B) in sealed opaque envelopes after determining its sequence. thereafter people who are undertaking enrolling, after checking the inclusion and exclusion criteria, open the envelope to determine the intervention group of each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each group(laser/sham) are named A or B by someone who is not involved in enrolling, evaluation and analysis. According to randomization table, sequence of block will be defined. (Permuted block randomization)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3582 0
Iran, Islamic Republic Of
State/province [1] 3582 0

Funding & Sponsors
Funding source category [1] 267080 0
Name [1] 267080 0
Tehran University of medical sciences
Address [1] 267080 0
Poor sina St, Enghelab Sq.
postal/ZIP: 1417613151
Country [1] 267080 0
Iran, Islamic Republic Of
Primary sponsor type
Tehran university of medical sciences
Poor sina St, Enghelab Sq,
postal/ZIP: 1417613151
Iran, Islamic Republic Of
Secondary sponsor category [1] 264169 0
Name [1] 264169 0
Masood Nabavi
Address [1] 264169 0
Mostafa Khomein hospital, Italia ST,

Postal/ZIP: 141665185
Country [1] 264169 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Ethics committee name [1] 269380 0
Ethic committee of Tehran University of medical science
Ethics committee address [1] 269380 0
poorsian St, Enghelab Sq, tahran, iran
postal/ZIP: 1417613151
Ethics committee country [1] 269380 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 269380 0
Approval date [1] 269380 0
Ethics approval number [1] 269380 0

Brief summary
Pain and sensory deficit is one of the main complaints of MS patients. Although there are some medical therapy for pain relief but they are associated with some side effects too; In the other hand low power laser is a secure and effective modality in relieving pain and dysesthesia from 2002 when FDA approve it.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32586 0
Address 32586 0
Country 32586 0
Phone 32586 0
Fax 32586 0
Email 32586 0
Contact person for public queries
Name 15833 0
Sadeghi Naini, Mohsen
Address 15833 0
Num29, Karimi Alley, Arash Blv, Zafar St.
Postal/ZIP: 1916649411
Country 15833 0
Iran, Islamic Republic Of
Phone 15833 0
Fax 15833 0
Email 15833 0
Contact person for scientific queries
Name 6761 0
Nabavi, seyed masoud
Address 6761 0
Mostafa Khomeini Hospital
Vesal St., Italia St.
Postal/ZIP 141665185
Country 6761 0
Iran, Islamic Republic Of
Phone 6761 0
Fax 6761 0
Email 6761 0

No information has been provided regarding IPD availability
Summary results
No Results